"Determining the impact of peer-led community-based PrEP delivery among sexual and gender minority youth in Brazil: A randomized controlled trial" - SUMMARY/ABSTRACT HIV is declining in many parts of the world, but rising in Latin America, including Brazil. From 2010 to 2019, the number of new HIV infections in Latin America increased 21%, compared to a global reduction of 23%. The number of reported HIV cases in Brazil increased from 13,719 in 2011 to 40,880 in 2021, with increases driven by sexual and gender minority youth aged 15-24 years (SGM youth). Among men aged 15-24 years, HIV incidence per 100,000 increased from 37.8 in 2000 to 66.5 in 2018 – a 75% increase. HIV pre-exposure prophylaxis (PrEP) was approved in Brazil in 2021 for adolescents aged 15-17 years, but PrEP uptake has been <1% among SGM youth. Our team conducted the first and largest PrEP demonstration study among adolescents in Latin America (PrEP1519), in which we implemented peer navigation strategies that linked 1174 SGM youth (20% of 5870 recruited) to PrEP services at SGM-affirming health facilities. In qualitative interviews, SGM youth articulated positive relationships with peer navigators but reluctance to engage with facility-based services due to past experiences with stigma and logistical and structural challenges accessing care. These data suggest that programs featuring peers were welcomed, but alternatives to facility-based services are urgently needed to scale up PrEP among SGM youth. We hypothesize that equipping peer lay workers – trained SGM youth who are part of SGM-affirming health care teams – to deliver PrEP to SGM youth in community venues will increase PrEP uptake among SGM youth. The goal of this project is to conduct a series of studies to refine, test, and understand experiences with a peer-led community-based intervention (CommunityPrEP, “COMPrEP”). In Aim 1, we will conduct qualitative interviews guided by the Consolidated Framework for Implementation Research to identify key modifications for the PrEP1519 peer navigator intervention to adapt it for community delivery by peer lay workers. In Aim 2, we will randomize 1400 SGM youth to access PrEP through peer lay workers at community venues (COMPrEP intervention) or health providers at SGM-affirming health facilities (standard care). We will conduct intent-to-treat analyses with modified Poisson regression to compare PrEP uptake (primary outcome) across randomized arms. We will follow the subset that initiates PrEP (expected to be N~385) for 12 months to compare secondary outcomes (1-month adherence, 3-month and 12-month persistence). Throughout the trial, we will monitor participant safety through our study team and an external monitoring board. In Aim 3, we will use the RE-AIM framework to explore experiences with the COMPrEP intervention through qualitative interviews with SGM youth, peer lay workers and health providers, and local and national policymakers to develop next steps. The proposed work will provide robust evidence about whether PrEP delivery facilitated by peer lay workers in community settings increases PrEP uptake, adherence, and persistence among SGM youth in Brazil. With members of the National HIV Program in Brazil as our collaborators, we will be well-positioned to provide results to guide programming for this population and scale up the intervention if effective.
